On June 29, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that its myChoice HRD test successfully identified an increased number of patients with ovarian cancer who may benefit from treatment with niraparib (Press release, Myriad Genetics, JUN 29, 2016, View Source [SID:1234513605]). Niraparib is an investigational oral PARP inhibitor being developed by TESARO (Nasdaq:TSRO).

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Today’s announcement follows results of the NOVA study (NCT01847274), which evaluated the safety and efficacy of niraparib as a maintenance therapy in more than 500 patients with recurrent ovarian cancer. The primary outcome was the prolongation of progression-free survival (PFS). Patients were divided into two groups: those with a germline BRCA mutation and those without. Patients without a germline BRCA mutation were evaluated for homologous recombination deficiency (HRD) using Myriad’s myChoice HRD test. Patients in both groups were randomized to receive niraparib or placebo.

The study demonstrated that the myChoice HRD test approximately doubled the number of patients who may benefit from niraparib treatment than identified by the current FDA-approved BRACAnalysis CDx test. Importantly, patients who were germline BRCA negative, but myChoice HRD positive, experienced over a threefold increase in median PFS with niraparib compared to placebo. The key findings are summarized in Table 1.

Table 1: NOVA Study Results

Companion Diagnostic Prolonged PFS Benefit
(Niraparib vs. Placebo) P-Value
myChoice HRD positive
(germline negative) 9.1 months
(12.9 vs. 3.8 months) P<0.0001
BRACAnalysis CDx positive
(germline positive) 15.5 months
(21.0 vs. 5.5 months) P<0.0001
"We are very excited about these strong clinical findings as they demonstrate a new paradigm to personalize PARP inhibitor treatment," said Mark Capone, president and CEO, Myriad Genetics. "We believe the myChoice HRD test is positioned to become the gold standard companion diagnostic for PARP inhibitors and will help physicians confidently select safe and effective treatment plans for their patients."

The myChoice HRD test is being developed in parallel with the clinical development of niraparib. The collaboration with TESARO began in March 2014 and includes several ongoing clinical trials in a variety of tumor types. myChoice HRD expands Myriad’s portfolio of precision medicine tests.

About myChoice HRD
Myriad’s myChoice HRD test is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD score is a composite of three proprietary technologies: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions. Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens. In December 2014, BRACAnalysis CDx was approved by the FDA as a companion diagnostic for Lynparza (olaparib) for patients with advanced ovarian cancer who have had three or more lines of chemotherapy

On June 29, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that its myChoice HRD test successfully identified an increased number of patients with ovarian cancer who may benefit from treatment with niraparib (Press release, Myriad Genetics, JUN 29, 2016, View Source [SID:1234513605]). Niraparib is an investigational oral PARP inhibitor being developed by TESARO (Nasdaq:TSRO).

Today’s announcement follows results of the NOVA study (NCT01847274), which evaluated the safety and efficacy of niraparib as a maintenance therapy in more than 500 patients with recurrent ovarian cancer. The primary outcome was the prolongation of progression-free survival (PFS). Patients were divided into two groups: those with a germline BRCA mutation and those without. Patients without a germline BRCA mutation were evaluated for homologous recombination deficiency (HRD) using Myriad’s myChoice HRD test. Patients in both groups were randomized to receive niraparib or placebo.

The study demonstrated that the myChoice HRD test approximately doubled the number of patients who may benefit from niraparib treatment than identified by the current FDA-approved BRACAnalysis CDx test. Importantly, patients who were germline BRCA negative, but myChoice HRD positive, experienced over a threefold increase in median PFS with niraparib compared to placebo. The key findings are summarized in Table 1.

Table 1: NOVA Study Results

Companion Diagnostic Prolonged PFS Benefit
(Niraparib vs. Placebo) P-Value
myChoice HRD positive
(germline negative) 9.1 months
(12.9 vs. 3.8 months) P<0.0001 BRACAnalysis CDx positive (germline positive) 15.5 months (21.0 vs. 5.5 months) P<0.0001 "We are very excited about these strong clinical findings as they demonstrate a new paradigm to personalize PARP inhibitor treatment," said Mark Capone, president and CEO, Myriad Genetics. "We believe the myChoice HRD test is positioned to become the gold standard companion diagnostic for PARP inhibitors and will help physicians confidently select safe and effective treatment plans for their patients." The myChoice HRD test is being developed in parallel with the clinical development of niraparib. The collaboration with TESARO began in March 2014 and includes several ongoing clinical trials in a variety of tumor types. myChoice HRD expands Myriad's portfolio of precision medicine tests. About myChoice HRD Myriad's myChoice HRD test is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD score is a composite of three proprietary technologies: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions. Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. About BRACAnalysis CDx BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens. In December 2014, BRACAnalysis CDx was approved by the FDA as a companion diagnostic for Lynparza (olaparib) for patients with advanced ovarian cancer who have had three or more lines of chemotherapy